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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA127971 | U.S. NIH Grant/Contract | View source | |
| CDR0000629579 | |||
| GCRC#724/819 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.
PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.
OBJECTIVES:
OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.
Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.
Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.
After completion of study treatment, patients are followed periodically for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Therapy + Placebo Testosterone | Placebo Comparator | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. |
|
| Standard of Care Therapy + Testosterone | Active Comparator | Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Testosterone | Drug | Placebo (Saline) Testosterone given IM once per week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. | Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported. | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Sheffield-Moore, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555-0361 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31391011 | Derived | Scott JM, Dillon EL, Kinsky M, Chamberlain A, McCammon S, Jupiter D, Willis M, Hatch S, Richardson G, Danesi C, Randolph K, Durham W, Wright T, Urban R, Sheffield-Moore M. Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial. BMC Cancer. 2019 Aug 7;19(1):778. doi: 10.1186/s12885-019-6006-5. |
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Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study.
Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I: Standard of Care Therapy + Placebo Testosterone | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone |
| FG001 | Arm II: Standard of Care Therapy + Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Study - Midpoint Study |
|
| |||||||||||||||||||||
| Midpoint Study - Post Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I: Standard of Care Therapy + Placebo Testosterone | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. | Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported. | Reporting data for the 22 completing subjects only, since this data is reported as change over time. | Posted | Mean | Standard Deviation | Percent change | 7 weeks |
|
7 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I: Standard of Care Therapy + Placebo Testosterone | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia Requiring Tranfusion | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | General disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Sheffield-Moore | University of Texas Medical Branch | 409-772-8707 | melmoore@utmb.edu |
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| ID | Term |
|---|---|
| D002100 | Cachexia |
| D002294 | Carcinoma, Squamous Cell |
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C004648 | testosterone enanthate |
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| Testosterone Enanthate 100 MG/ML | Drug | Testosterone Enanthate 100mg/ml given once per week IM. |
|
| Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication. | 7 weeks |
| Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. | Baseline |
| Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec. | 7 weeks |
| Body Weight as Measured by Scale at Baseline | Body weight in kilograms as measured by a scale at the baseline visit. | Baseline |
| Body Weight as Measured by Scale at 7 Weeks. | Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication. | 7 weeks |
| Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. | Baseline |
| Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. | 7 weeks |
| Physical Activity Levels as Measured by the ActiGraph Accelerometer | Physical activity is reported as % time sedentary for the entire 7 week study. | through study completion,up to 7 weeks |
| Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Baseline |
| Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | baseline |
| Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | 7 weeks |
| Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline | Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit | baseline |
| Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks | Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit. | 7 weeks |
| Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99. | baseline |
| Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99 | 7 weeks |
| Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. | Baseline |
| Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. | 7 weeks |
| Mood Measured by Profile of Mood States at Baseline | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). | baseline |
| Mood as Measured by Profile of Mood States at 7 Weeks | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). | 7 weeks |
| Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). | Baseline |
| Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). | 7 weeks |
| 1-year Survival | Number of participants who survived one year post study. | 1 year post study |
| NOT COMPLETED |
|
| BG001 |
| Arm II: Standard of Care Therapy + Testosterone |
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Arm II: Standard of Care Therapy + Testosterone |
Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
|
|
| Secondary | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. | 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer. | Posted | Mean | Standard Deviation | Newton-Meters | Baseline |
|
|
|
| Secondary | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication. | Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. | Posted | Mean | Standard Deviation | Newton-Meters | 7 weeks |
|
|
|
| Secondary | Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. | 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer. | Posted | Mean | Standard Deviation | Watts | Baseline |
|
|
|
| Secondary | Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec. | Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. | Posted | Mean | Standard Deviation | Watts | 7 weeks |
|
|
|
| Secondary | Body Weight as Measured by Scale at Baseline | Body weight in kilograms as measured by a scale at the baseline visit. | 24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point. | Posted | Mean | Standard Deviation | Kilograms | Baseline |
|
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| Secondary | Body Weight as Measured by Scale at 7 Weeks. | Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication. | 22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit. | Posted | Mean | Standard Deviation | Kilograms | 7 weeks |
|
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| Secondary | Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. | 24 subjects completed this outcome measure at the baseline visit. | Posted | Mean | Standard Deviation | kilo-calories per day | Baseline |
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| Secondary | Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. | Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. | Posted | Mean | Standard Deviation | kilo-calories per day | 7 weeks |
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| Secondary | Physical Activity Levels as Measured by the ActiGraph Accelerometer | Physical activity is reported as % time sedentary for the entire 7 week study. | Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed. | Posted | Mean | Standard Deviation | % time sedentary | through study completion,up to 7 weeks |
|
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| Secondary | Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
|
|
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| Secondary | Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
|
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| Secondary | Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
|
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| Secondary | Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
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| Secondary | Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
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| Secondary | Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
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| Secondary | Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
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| Secondary | Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | Baseline |
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| Secondary | Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | baseline |
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| Secondary | Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. | Blood was collected for this outcome from only 18 subjects. | Posted | Mean | Standard Deviation | picogram/milliliter | 7 weeks |
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| Secondary | Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline | Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit | 24 subjects were able to complete this outcome measure at the baseline study visit. | Posted | Mean | Standard Deviation | grams | baseline |
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| Secondary | Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks | Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit. | 24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks. | Posted | Mean | Standard Deviation | grams | 7 weeks |
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| Secondary | Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99. | 20 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | units on a scale | baseline |
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| Secondary | Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99 | 21 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | Units on a scale | 7 weeks |
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| Secondary | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. | 21 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
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| Secondary | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. | 20 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | Units on a scale | 7 weeks |
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| Secondary | Mood Measured by Profile of Mood States at Baseline | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). | 22 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | units on a scale | baseline |
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| Secondary | Mood as Measured by Profile of Mood States at 7 Weeks | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). | 20 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | Units on a scale | 7 weeks |
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| Secondary | Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). | 19 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline |
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| Secondary | Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). | 20 subjects completed this questionnaire at this time point. | Posted | Mean | Standard Deviation | scores on a scale | 7 weeks |
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| Secondary | 1-year Survival | Number of participants who survived one year post study. | 12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group. | Posted | Count of Participants | Participants | 1 year post study |
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| 0 |
| 12 |
| 6 |
| 12 |
| 6 |
| 12 |
| EG001 | Arm II: Standard of Care Therapy + Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate | 0 | 12 | 6 | 12 | 3 | 12 |
| Duodenal Ulcer | Gastrointestinal disorders | Duodenal Ulcer that caused anemia and required a blood tranfusion |
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| Cerebrovascular Accident | Vascular disorders |
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| Anaphylactic shock | General disorders | Anaphylactic shock to chemotherapy agen |
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| Pneumonia | Infections and infestations |
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| Deep Vein Thrombosis | Vascular disorders |
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| Sycope | General disorders | Syncope resulting in a fall with broken arm |
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| Fever | Infections and infestations | Fever requiring anitbiotics |
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| Neutropenic Fever | Infections and infestations |
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| Urinary Tract Infection | Renal and urinary disorders |
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| Thrombocytosis | Blood and lymphatic system disorders |
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| Altered Mental State | Psychiatric disorders |
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| Hyponatremia | Blood and lymphatic system disorders |
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| Vesicovaginal Fistula | Reproductive system and breast disorders |
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| Metastatic Bowel Obstruction | Gastrointestinal disorders |
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Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |